Invivyd's COVID Antibody PEMGARDA Retains Neutralization Power Against Key Variants, FDA Confirms
Invivyd's COVID Antibody PEMGARDA Retains Neutralization Power Against Key Variants, FDA Confirms
Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has re-issued an updated Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers (Fact Sheet) for PEMGARDA (pemivibart) to provide accurate in vitro neutralization activity of PEMGARDA against dominant circulating variants including KP.3.1.1 and LB.1.
致力于提供严重病毒性传染病防护的生物制药公司Invivyd, Inc.（纳斯达克股票代码：IVVD）今天宣布，美国食品药品监督管理局（FDA）已为PEMGARDA（pemivibart）重新发布了最新的医疗保健提供商紧急使用授权（EUA）情况说明书（情况说明书），以提供PEMGARDA对主要循环变体的准确体外中和活性包括KP.3.1.1和Lb.1。
The FDA's newly updated Fact Sheet, dated September 26, 2024, removes a contested statement that "preliminary, non-peer-reviewed data in the public domain indicate that KP.3.1.1 may have substantially reduced susceptibility to pemivibart." The FDA has now included viral neutralization data for pemivibart that is in line with prior variants represented in the CANOPY Phase 3 clinical trial based on data generated by LabCorp's Monogram Biosciences lab and provided to the FDA on September 3, 2024, and determined that PEMGARDA is likely to retain adequate neutralization activity against SARS-CoV-2 variants currently circulating in the U.S., including KP.3.1.1 (FDA updates PEMGARDA's SARS-CoV-2 variant susceptibility data).
美国食品药品管理局于2024年9月26日发布的最新情况说明书删除了一份有争议的声明，即 “公共领域未经同行评审的初步数据表明，KP.3.1.1可能已大大降低了对pemivibart的敏感性。”根据LabCorp的Monogram Biosciences实验室生成并于2024年9月3日提供给美国食品药品管理局的数据，美国食品药品管理局现已纳入pemivibart的病毒中和数据，该数据与CANOPY 3期临床试验中的先前变体一致，并确定PEMGARDA可能对目前在美国流通的SARS-CoV-2变体（包括KP.3.1.1）保持足够的中和活性（美国食品药品管理局更新 PEMGARDA）DA 的 SARS-CoV-2 变体易感性数据）。
Various laboratories, which may have competing or conflicting interests with Invivyd's core COVID-19 antibody business, may produce their own reagents meant to resemble pemivibart, and may put neutralization findings of unknown quality into the public domain. Invivyd, as a matter of policy and in partnership with the FDA, relies on the high standard of assessing authentic pemivibart under industrial-quality conditions to assess pemivibart neutralization potency and likely variant susceptibility. Such procedural rigor is critical given the difficulty of cellular bioassay development and validation and intrinsic quantitative variability of these assays even when conducted under highly controlled conditions. Invivyd encourages all stakeholders to rely on validated, scientific studies conducted with authentic pemivibart and to exercise caution when assessing the potential relevance of virology work performed under conditions of questionable quality and control.
可能与 Invivyd 的核心 COVID-19 抗体业务存在竞争或利益冲突的各种实验室可能会自己生产类似于 pemivart 的试剂，并可能将质量未知的中和发现公之于众。作为一项政策，Invivyd与美国食品药品管理局合作，依靠在工业质量条件下评估正宗pemivart的高标准来评估pemivbart的中和效力和可能的变种敏感性。鉴于细胞生物测定难以开发和验证，而且即使在高度受控的条件下进行这些测定也具有内在的定量变异性，因此如此严格的程序至关重要。Invivyd 鼓励所有利益相关者依赖经过验证的、使用正宗的 pemivibart 进行的科学研究，并在评估在质量和控制可疑的条件下开展的病毒学工作的潜在相关性时谨慎行事。
